Public Citizen calls for FDA to pull J&J’s birth control patch

WASHINGTON The consumer advocacy group Public Citizen petitioned the Food and Drug Administration yesterday to take Ortho-Evra, Johnson & Johnson’s birth control patch, off the market, saying that its far riskier than the pill, according to the Associated Press.

Warnings about the Ortho-Evra weekly patch have escalated since a 2005 investigation by The Associated Press found patch users suffer higher rates of life-threatening blood clots than women who take birth-control pills because they absorb up to 60 percent more estrogen than pill users. The FDA did update Ortho-Evra’s label in 2005, 2006 and earlier this year with clot warnings.

Sidney Wolfe of Public Citizen argued in the letter that the patch offers no better contraception in return for the extra risk. And he said lawsuits by women who claim they were harmed by the patch have unearthed two previously unpublished studies from Johnson & Johnson researchers that found higher estrogen exposure from the patch even before it won FDA approval in 2001.

Gloria Vanderham, a spokeswoman for patch maker Ortho Women’s Health & Urology, said “Ortho-Evra is a safe and effective hormonal birth control option when used according to its labeling.”

“Hormonal birth control methods have benefits and risks,” said Vanderham. “The approved labeling has always stated the known risks associated with its use.”

The FDA told the AP it has not had an opportunity to review the petition and, when it does, it will respond directly to Public Citizen.